Q2 2021 Results - Reimagining Medicine
Participants
Company overview
Pharmaceuticals
Oncology
Financial performance
CRM
IHD
Neuroscience
Oncology
Ophthalmology
Financial review
Conclusion
Appendix
Innovation: Pipeline overview
Respiratory
References
Innovation: Clinical trials
Abbreviations
Sandoz Biopharmaceuticals
Global Health
PromactaⓇ/Revolade® - Thrombopoetin receptor agonist
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
Read-out Milesstone(s)
NCT03025698 (CETB115E2201)
Previously untreated or relapsed/refractory severe aplastic anemia or recurrent
aplastic anemia
Phase 2
60
PK of eltrombopag at steady state in pediatric patients with SAA
Eltrombopag 12.5, 25, 50, 75 mg FCT & 25 mg pFOS
Arm A: relapsed/refractory SAA or recurrent AA following IST for
SAA: hATG/cyclosporine + eltrombopag or cyclosporine + eltrombopag
Arm B: previously untreated SAA: hATG/cyclosporine + eltrombopag
Pediatric patients from age 1 <18 years with relapsed/refractory SAA or recurrent
AA after IST or previously untreated SAA
Primary CSR: 2022
Final CSR: 2025
NCT03988608 (CETB115E2202)
Previously untreated or relapsed/refractory severe aplastic anemia or recurrent
aplastic anemia
Phase 2
20
Hematologic response rate rate up to 26 weeks of treatment
Eltrombopag 25 mg film-coated tablets
Chinese patients with refractory or relapsed severe aplastic anemia
Primary: 2021; Final: 2023
Publication
TBD
111 Investor Relations | Q2 2021 Results
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